The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects

NCT ID: NCT00273104

Last Updated: 2018-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2017-12-31

Brief Summary

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This follow up study (\>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

Detailed Description

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Not addressed

Conditions

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Obstructive Sleep Apnea Diabetes Mellitus Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bariatric surgery

Bariatric surgery (gastric bypass) offered to patients after informed consent and shared decision. The surgical procedure was performed at Vestfold Hospital Trust by experienced bariatric surgeons.

Group Type ACTIVE_COMPARATOR

Bariatric surgery

Intervention Type PROCEDURE

Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.

Intensive lifestyle intervention

Intensive lifestyle intervention (1-year endurance) at a rehabilitation centre. The intervention consisted of motivation for behaviour change including calorie restriction and increased physical activity.

Group Type ACTIVE_COMPARATOR

Intensive lifestyle intervention

Intervention Type BEHAVIORAL

Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.

Interventions

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Bariatric surgery

Bariatric surgery as a part of public health service offered treatment seeking morbidly obese patients.

Intervention Type PROCEDURE

Intensive lifestyle intervention

Intensive lifestyle intervention as a part of public health service offered treatment seeking morbidly obese patients.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Morbidly obese patients

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South-Eastern Norway Regional Health Authority

OTHER

Sponsor Role collaborator

The Hospital of Vestfold

OTHER

Sponsor Role lead

Responsible Party

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Jøran Hjelmesæth

Head of Morbid Obesity Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jøran Hjelmesæth, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital of Vestfold

Locations

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Hospital in Vestfold

Tønsberg, , Norway

Site Status

Countries

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Norway

References

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Gabrielsen AM, Omland T, Brokner M, Fredheim JM, Jordan J, Lehmann S, Lund MB, Hjelmesaeth J, Hofso D. The effect of surgical and non-surgical weight loss on N-terminal pro-B-type natriuretic peptide and its relation to obstructive sleep apnea and pulmonary function. BMC Res Notes. 2016 Sep 13;9(1):440. doi: 10.1186/s13104-016-2241-x.

Reference Type DERIVED
PMID: 27619215 (View on PubMed)

Hofso D, Birkeland KI, Holst JJ, Bollerslev J, Sandbu R, Roislien J, Hjelmesaeth J. Gastric bypass surgery has a weight-loss independent effect on post-challenge serum glucose levels. Diabetol Metab Syndr. 2015 Aug 22;7:69. doi: 10.1186/s13098-015-0066-8. eCollection 2015.

Reference Type DERIVED
PMID: 26300987 (View on PubMed)

Gabrielsen AM, Lund MB, Kongerud J, Viken KE, Roislien J, Hjelmesaeth J, Hofso D. Pulmonary function and blood gases after gastric bypass and lifestyle intervention: a comparative study. Clin Obes. 2013 Oct;3(5):117-23. doi: 10.1111/cob.12024. Epub 2013 Jul 8.

Reference Type DERIVED
PMID: 25586626 (View on PubMed)

Karlsen TI, Lund RS, Roislien J, Tonstad S, Natvig GK, Sandbu R, Hjelmesaeth J. Health related quality of life after gastric bypass or intensive lifestyle intervention: a controlled clinical study. Health Qual Life Outcomes. 2013 Feb 13;11:17. doi: 10.1186/1477-7525-11-17.

Reference Type DERIVED
PMID: 23406190 (View on PubMed)

Nordstrand N, Hertel JK, Hofso D, Sandbu R, Saltvedt E, Roislien J, Os I, Hjelmesaeth J. A controlled clinical trial of the effect of gastric bypass surgery and intensive lifestyle intervention on nocturnal hypertension and the circadian blood pressure rhythm in patients with morbid obesity. Surgery. 2012 May;151(5):674-80. doi: 10.1016/j.surg.2011.12.007. Epub 2012 Jan 18.

Reference Type DERIVED
PMID: 22261295 (View on PubMed)

Fredheim JM, Rollheim J, Omland T, Hofso D, Roislien J, Vegsgaard K, Hjelmesaeth J. Type 2 diabetes and pre-diabetes are associated with obstructive sleep apnea in extremely obese subjects: a cross-sectional study. Cardiovasc Diabetol. 2011 Sep 25;10:84. doi: 10.1186/1475-2840-10-84.

Reference Type DERIVED
PMID: 21943153 (View on PubMed)

Hofso D, Jenssen T, Bollerslev J, Ueland T, Godang K, Stumvoll M, Sandbu R, Roislien J, Hjelmesaeth J. Beta cell function after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention. Eur J Endocrinol. 2011 Feb;164(2):231-8. doi: 10.1530/EJE-10-0804. Epub 2010 Nov 15.

Reference Type DERIVED
PMID: 21078684 (View on PubMed)

Hofso D, Nordstrand N, Johnson LK, Karlsen TI, Hager H, Jenssen T, Bollerslev J, Godang K, Sandbu R, Roislien J, Hjelmesaeth J. Obesity-related cardiovascular risk factors after weight loss: a clinical trial comparing gastric bypass surgery and intensive lifestyle intervention. Eur J Endocrinol. 2010 Nov;163(5):735-45. doi: 10.1530/EJE-10-0514. Epub 2010 Aug 26.

Reference Type DERIVED
PMID: 20798226 (View on PubMed)

Other Identifiers

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S-05175

Identifier Type: -

Identifier Source: org_study_id

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